Job description Posted 06 December 2021

Qualified Person

Contract until December 2022

Up to £947 per day via Umbrella inside IR35

Must be eligible to act as a Qualified Person, is personally accountable to conform to the legal regulatory requirements as stated in Clinical trials - Directive 2001/20/EC and Article 51 of Directive 2001/83/EC.

Will be responsible for the certification of finished Investigational Medicinal Product and release of investigational medicinal bulk product.

GSK have a challenging and inspiring mission: to improve the quality of human life by enabling people to do more, feel better and live longer.

An exciting opportunity has arisen for Qualified Person to join the Pharma R&D Team.

The Qualified Person will have responsibility for delivering effective, safe and compliant leadership and management of the QA function.

The successful person will perform the quality assurance activities and quality oversight of the GMP functions performed within Pharma R&D, Fulfilling the Qualified person responsibilities defined 2001/20/EC and Article 51 of Directive 2001/83/EC. (including Release of Product into the EU which has been manufactured outside EU).

Key Responsibilities include, but are not limited to:

• Develop and incorporate effective processes and procedures in Product Quality Pharma R&D and may contribute to business processes and procedures outside Product Quality Pharma R&D

• Assure products meet regulatory requirements and that they conform to regulatory submissions.

• May interact with regulators.

• May participate in/manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high risk non-compliance issues.

• Identify business or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions.

• Provide advice and consultancy to GSK project teams and external partners to reduce regulatory risk to GSK.

• May represent the group as a primary business contact for specific areas.

• Identify and mitigate compliance risks to GSK through effective assessments and/or via providing advice and consultancy to Product Quality Pharma R&D and business units regionally and globally.

• Liaise with customers to provide compliance advice/input.